Feiba Description

Powder and solvent for solution for infusion.
White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6.
Each Factor VIII Inhibitor Bypassing Activity (Feiba) is formulated as a sterile, non-pyrogenic freeze-dried powder or friable mass. Each strength is supplied with a vial of sterile water for injection as diluent for reconstitution prior to intravenous injection. The reconstituted solution has a nominal activity of 50 U/mL and has a nominal potency of 500 units (U) per vial.
Active substance: Factor VIII Inhibitor Bypassing Activity.
1 ml contains 50 U* factor VIII inhibitor bypassing activity.
Factor VIII Inhibitor Bypassing Activity (Feiba) 50 U/ml is available in one presentation: The presentation 500 U Factor VIII Inhibitor Bypassing Activity (Feiba) contains 500 U factor VIII inhibitor bypassing activity in 200-600 mg human plasma protein.
Factor VIII Inhibitor Bypassing Activity (Feiba) also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VII. Factor VIII coagulation antigen (F VIII C:Ag) is present at a concentration of up to 0.1 U./1 U. Factor VIII Inhibitor Bypassing Activity (Feiba). The factors of the kallikrein-kinin system are present in trace amounts only, if at all.
* 1 unit of Factor VIII Inhibitor Bypassing Activity (Feiba) shortens the activated partial thromboplastin time (aPTT) of a factor VIII inhibitor plasma by 50% of the buffer value (blank value).
Excipients with known effect: 500 U: Factor VIII Inhibitor Bypassing Activity (Feiba) contains approximately 40 mg sodium per vial.
Excipients/Inactive Ingredients: Powder: Sodium chloride, Sodium citrate.
Solvent: Water for Injections.